Oracle announced that is collaborating with dMed in China as rapidly emerging local Chinese biopharma companies look to meet growing regulatory compliance and safety management requirements but do not have the resources, systems and skills in-house.
There is an increase in clinical trials in China, deepening regulatory reform at CFDA, and China's new membership at ICH. All of these changes have heightened the importance of global alignment on clinical development and post approval responsibilities. One of the areas lagging is drug safety and pharmacovigilance. This has resulted in the strong need for a reliable drug safety database that helps meet international safety standards.
"This is why dMed decided to work with Oracle Health Sciences," said Dr. Lingshi Tan, Chairman and CEO, dMed Biopharmaceutical. "The Oracle Argus Safety system enables our Pharmacovigilance experts to provide comprehensive case management and safety reporting services. The ability of accessing a reliable drug safety database helps customers meet international safety standards and make better safety decisions."
By collaborating with Oracle Health Sciences on business process services, dMed aims to help its clients to optimize global compliance and integrate risk management into key processes. Local sponsors such as Hua Medicine, Zai Lab and others are leveraging these services and the Argus platform to meet their Safety and compliance requirements.